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Characterization and Identification of Subvisible Protein and Polysorbate Aggregates in Protein Therapeutics
Wednesday, June 22, 2022 – 8:00 am (PDT)
Polysorbates 20 and 80 are excipients used in >70% of marketed parenteral biological drugs to improve product stability and shelf life. However, unwanted visible and subvisible particles are formed when formulations containing these excipients are stored for long periods of time at low temperatures.
When determining formulations for biologics, developers need high-throughput, sensitive, and utilitarian tools with specific analysis of proteins and polysorbate particles for complex chemistries. Additionally, these analytes exist in extremely low concentrations, so they remain undetectable when using techniques such as optical imaging.
Halo Labs has addressed all these needs and more. With Aura PTx™, polysorbates are quickly identified and distinguished from other particle types. Using Aura’s high throughput and low volume format, months of development time can be saved by knowing the source of particles in your formulation and distinguishing aggregated drug product from degraded excipients.
Continuity of Methods: Characterizing Protein Therapeutic Stability From Developability Assessment to Release With Aura PTx
Thursday, March 10, 2022 – 8:00 am (PDT)
Aura PTx is a complete protein therapeutic stability solution that enables characterization of subvisible particle aggregates from developability assessment through product release. Aura PTx is a high throughput analytical instrument that images, counts, sizes, and identifies subvisible particle aggregates, a critical quality attribute, and the most important biologic stability parameter. Using volumes as low as 10 µL and with measurements of one minute per sample, Aura PTx enables rapid, high contrast and thorough subvisible particle screening and absolute particle quantification.
In addition, it is powered by fluorescence membrane microscopy, a proprietary technique that enables individual particle identification analysis, which is helpful to identify and segment particles as protein aggregates, degraded polysorbate particles, and other particulate impurities relevant to protein therapeutic development.
In this talk, we overview the ability to perform subvisible particle analysis from cell line development through developability assessment, into product development and release as it is USP 1788 Method 2 compliant.
